FDA.report

Medline

Primary DI
40080196739487
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP7001
Catalog number
DYNJP7001
Device description
DRAPE,EENT,SPLIT,STERILE
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, surgical
PUIDrape, Surgical, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196739487PackageGS18In Commercial Distribution
10080196739486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019673948740080196739487
1008019673948610080196739486

GMDN Terms

TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a single-use device.

Device Sizes

TypeValueUnit
Length78Inch
Width121Inch

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00The contents of this package may burn if exposed to a flame or extremely hot objext. Avoid contact with an open flame or high intensity heat.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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